AU2024202025A1 - Nerve regeneration system and method - Google Patents

Abstract

An electrical stimulation system includes a stimulation device comprising a housing; control circuitry operatively generating a stimulation signal, wherein the control circuitry is disposed within the housing; an operative element coupled with the housing and comprising at least one electrode; an adaptor selectively attached to the operative element, the adaptor comprising a percutaneous lead electrically coupled to the stimulation device through the at least one electrode, the percutaneous lead insertable into a patient during a subcutaneous surgery and after the subcutaneous surgery and wherein the stimulation device is capable of applying electrical stimulation during the subcutaneous surgery and after the subcutaneous surgery; and a splitter device provided between the stimulation device and the percutaneous lead, and including an input port and one or more output ports, the stimulation signal is input via the input port and output via the one or more output ports, applying a prolonged stimulation signal to multiple tissue regions. Fig. 1 28/03/24 1/8 100 102 108 10 108 11110 1110 t32 120 112i 12 114 130 FIG.1 100 102 10\ 11 132 122 12 116 124 130 FIG. 2

Description

1/8

100 102 108 108 11110

1110

t32 120 112i 12 114

130 FIG.1 100 102

10\ 11

132 122 12 116 124 130

FIG. 2

AUSTRALIA Patents Act, 1990 ORIGINAL COMPLETE SPECIFICATION

APPLICANT/S: Checkpoint Surgical, Inc. (a Delaware Corporation)

INVENTORS: SCANLAN, Kevin WALKER, Eric R. COSENTINO, Leonard M.

ADDRESS FOR SERVICE: Maxwells Patent & Trade Mark Attorneys Pty Ltd PO Box R1466 Royal Exchange Sydney, NSW, 1225

INVENTION TITLE: NERVE REGENERATION SYSTEM AND METHOD

DIVISIONAL OF AU - 2018 290 344 - 22 June 2018

PRIORITY: US - 62/523,300 - 22 June 2017

The following statement is a full description of this invention including the best method of performing it known to the applicant:

TITLE NERVE REGENERATION SYSTEM AND METHOD CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] Thisapplication claims the benefit of U.S. Provisional Patent Application No.

62,523,300, entitled "NERVE REGENERATION SYSTEM AND METHOD," filed

on June 22, 2017, which is hereby incorporated by reference.

FIELD OF THE INVENTION

00021 The invention relates generally to nerve regeneration, and more particularly to

systems and methods for accelerating or enhancing regrowth of injured or potentially

injured nerves undergoing treatment or surgical repair.

BACKGROUND OF THE INVENTION

[0003] Nerve injuries present clinicians with significant challenges in determining the

proper course of treatment to restore impaired motor and or sensory function.

Ultimately,.-the-.severity__of the nerve injury--and time post-injury have-the greatest

influence on the treatment plan and potential for success. In many cases surgical

intervention may be needed to increase the likelihood that control of muscle function

or sensation can be regained. Surgical treatment of nerve injuries typically does not

provide immediate restoration of function, as nerve fibers must grow from the point of

intervention or repair to the target muscle. Nerve fibers grow at a rate of1mm/day,

and thus recovery takes a significant amount of time.

la

[0004] Despite advancements in surgical technique and medical device technology,

the rate of growth and organization of fiber growth direction remains a significant

factor limiting functional outcomes.

[0005] It may be desirable to provide a method for delivering a period of electrical

stimulation as soon as possible, prior to or following repair, preferably while still in

the operating room, to improve functional outcome. Furthermore, it may be desirable

to be able to initiate a period of stimulation in the operating room and continuing into

a post-operative setting without interrupting stimulation. It may alternatively or

additionally be desirable to initiate stimulation during surgery or after surgery.

Moreover, stimulation may be initiated in an office or an operating room and may

continue while the patient moves between rooms. Additionally, it may be desirable to

deliver repeated periods of stimulation during recovery, without the need to replace

electrode(s) before each application.

SUMMARY OF THE INVENTION

[0006] The following presents a summary of this disclosure to provide a basic

understanding of some aspects. This summary is intended to neither identify key or

critical elements nor define any limitations of embodiments or claims. Furthermore,

thissummary- may- provide a simplified--overview of -some aspects-that- may---be

described in greater detail in other portions of this disclosure.

[0007] A system for stimulating tissue is described herein. The stimulation system

may include a stimulation device comprising a housing, control circuitry disposed

within the housing, an operative element coupled with the housing and comprising at

least one electrode, a percutaneous lead operatively attachable to the stimulation

device, and a container operatively receiving the stimulation device, wherein the container comprises at least one connection port that operatively and electrically couples the stimulation device to the percutaneous lead.

[0008] A method for stimulating tissue is described herein. The method may include

performing a subcutaneous operating with a handheld stimulation device, placing a

percutaneous lead at a target tissue region, wherein the percutaneous lead is

operatively attached to a stimulation device that may be handheld, closing an incision,

and applying a stimulation signal to the target tissue region with the percutaneous lead

and the stimulation device after the closing of the incision.

[0009] The following description and the drawings disclose various illustrative

aspects. Some improvements and novel aspects may be expressly identified, while

others may be apparent from the description and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[00011 The accompanying drawings illustrate various systems, apparatuses, devices

and methods, in which like reference characters refer to like parts throughout.

[0010] FIG. I illustrates a partial cross-sectional view of a stimulation device, in

accordance with various disclosed aspects;

[0011] FIG. 2 illustrates a side view of the stimulation device of FIG. 1, in accordance

with various disclosed-aspects;---- -- -- -

[0012]FIG. 3 illustrates a percutaneous electrode, in accordance with various

disclosed aspects;

10013jFIG. 4A illustrates another percutaneous electrode, in accordance with various

disclosed aspects;

[0014] FIG. 4B illustrates another percutaneous electrode, in accordance with various

disclosed aspects;

[0015] FIG. 5 illustrates an adaptor comprising a percutaneous electrode, in

accordance with various disclosed aspects;

[00161 FIG. 6 illustrates an adaptor comprising two connectors, in accordance with

various disclosed aspects;

100171 FIG. 7 illustrates the stimulation device of FIG. I coupled with an adaptor, in

accordance with various disclosed aspects;

10018] FIG. 8 illustrates a top view of a container for receiving a stimulation device,

in accordance with various disclosed aspects;

[0019]1 FIG. 9 illustrates a top view of another container for receiving a stimulation

device, in accordance with various disclosed aspects;

[0020] FIG. 10 illustrates a back view of the container of FIG. 9, in accordance with

various disclosed aspects;

[0021] FIG. Ii illustrates a system comprising thecontainer of FIG. 8,the stimulation

device of FIG. 1, and electrode connections, in accordance with various disclosed

aspects;

[0022] FIG. 12 illustrates a perspective view of a splitter device, in accordance with

various disclosed aspects;

[00231 FIG.13 illustrates a partial cross-sctional, perspective view of a splitter

device, in accordancewith various disclosed aspects;

10024] FIG. 14 illustrates a perspective view of the splitter device of FIG. 12 coupled

with percutaneous leads, in accordance with various disclosed aspects;

[00251 FIG. 15 illustrates a perspective view of another stimulation device, in

accordance with various disclosed aspects;

[00261 FI1 16 illustrates an embodiment of the stimulation device in FIG. 15 without

a belt in accordance with various disclosed aspects;

[00271FIG. 17 illustrates a back view of the stimulation device of FIG. 16, in

accordance with various disclosed aspects; and

[0028] FIG. 18 illustrates an embodiment of the stimulation device in FIG. 15 with

one or more percutaneous leads and a return electrode, in accordance with various

disclosed aspects.

100291The invention may be embodied in several forms without departing from its

spirit or essential characteristics. The scope of the invention is defined in the

appended claims, rather than in the specific description preceding them. All

embodiments that fall within the meaning and range of equivalency of the claims are

therefore intended to be embraced by the claims.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0030] Reference will now be made in detail to exemplary embodiments of the

present invention, examples of which are illustrated in the accompanying drawings. It

is to be understood that other embodiments may be utilized, and structural and

functional changes may be made without departing from the respective scope of the

invention. Moreover, features of the various embodiments may be combined or

altered without departing from the scope of the invention. As such, the following

description_ is-presented by way of illustration only and should not limit in any way

the various alternatives and modifications that may be made to the illustrated

embodiments and still be within the spirit and scope of the invention.

[0031] As used herein, the words "example" and "exemplary" mean an instance, or

illustration, The words "example" or "exemplary" do not indicate a key or preferred

aspect or embodiment. The word "or" is intended to be inclusive rather an exclusive,

unless context suggests otherwise. As an example, the phrase "A employs B or C,"

includes any inclusive permutation (e.g., A employs B; A employs C; or A employs both B and C). As another matter, the articles "a" and "an" are generally intended to mean "one or more" unless context suggests otherwise.

[0032] It is noted that the various embodiments described herein may include other

components and/or functionality. It is further noted that while various embodiments

refer to a stimulator or stimulation device, various other systems may be utilized in

view of embodiments described herein. For example, embodiments may be utilized in

a variety of surgical procedures. As such, embodiments may refer to a particular

surgical procedure for purposes of explanation. It is noted that aspects of

embodiments, however, may be utilized for various other procedures.

[0033] This disclosure generally- relates to systems and methods that may improve

nerve regeneration or neuroregeneration of tissue via electrical stimulation to increase

the speed or amount of nerve growth. The terms "nerve" or "nerve tissue" generally

refer to any portion of a nerve including, but not limited to, axons, axon terminals,

somas, dendrites, or the like, unless context suggest otherwise. Moreover, aspects

disclosed herein may be applicable to nerve tissue throughout a body, whether

peripheral nervous tissue or otherwise. Further, while embodiments may reference a

surgeon performing a particular action(s), it is noted that other users, automated

.... machines, or-the.like may perform such- actions;.- -

[0034] It is noted that described systems and methods may be utilized in combination

with various systems and methods for safeguarding against nerve, muscle, and tendon

injury during surgical procedures or confirming the identity and/or location of nerves,

muscles, and tendons and evaluating their function or the function of muscles

enervated by those nerves. The systems and methods are particularly well suited for

assisting in nerve regeneration via a device that may also be utilized by a surgeon in

identification of nerves and muscles in order to assure nerve and muscle integrity during medical procedures using medical devices such as stimulation monitors, cutting, drilling, and screwing devices, pilot augers, and fixation devices, Further, the systems and methods may be utilized in surgery so as to identify the nerve and/or to deliver stimulation for nerve regeneration. This stimulation may be delivered during surgery prior to repair or treatment of the nerve injury and/or following repair or treatment of the nerve injury and/or continue post-surgery. It is noted, however, that various disclosed aspects may be utilized independent of such systems and methods.

[0035] For example, a surgeon may utilize a handheld stimulation device to generate

a stimulation signal at sufficiently high levels for the purposes of locating,

stimulating, and evaluating nerve or muscle, or both nerve and muscle integrity in

numerous medical procedures, including, but not limited to, evaluating proximity to a

targeted tissue region, evaluating proximity to a nerve or to identify nerve tissue,

evaluating nerve integrity (i.e., following a traumatic or repetitive motion injury) to

determine if a repair may be needed, evaluating muscle contraction to determine

whether or not the muscle is innervated and/or whether the muscle is intact and/or

whether the muscle is severed, identifying specific nerve branches or fascicles for

repair or transfer, and evaluating muscle and tendon length and function following a

repair or tendon.transfer _prior .to_.completing a surgical-procedure-Before,-after or--

during a procedure, a surgeon may place an electrode or lead on or near the nerve to

be stimulated and/or proximal to the site of injury or repair. The electrode may be

percutaneous or non-percutaneous (e.g., surface electrode). In an aspect, a

percutaneous lead may be taped or otherwise held in place on a patient's skin. This

may allow for easy removal after the prolonged stimulation. One exemplary

embodiment of such comprises a patch that may be adhered to the skin of a patient.

The patch may generally circumscribe the insertion point of the percutaneous lead and may allow a portion of the lead to extend therethrough. In this embodiment, a connector may be utilized to operatively couple of the percutaneous lead with the stimulation device, Alternatively, the lead may be operatively coupled with the patch and the patch may include an adapter that operatively couples with the stimulation device. The patch may include an electrical path between the percutaneous lead and the adapter such that electrical stimulation may pass from the stimulation device through the patch and to the percutaneous lead. The lead may be coupled to a stimulation device that was used during surgery, or another stimulation device, via a wire or other connector. The stimulation device may be placed in a sealed housing to prevent contamination when leaving the operating room into a post-operative setting or to maintain a fixed position. The housing may comprise a port that may allow the lead to be coupled with the stimulation device, and another port to connect a percutaneous or surface electrode, such as a patch, as a return current path. The stimulation device may generate a signal to stimulate the nerve tissue.

[0036] In an aspect, the stimulation device may generate the signal to stimulate the

nerve tissue following a procedure or prior to surgical completion. Placement of a

percutaneous lead may allow a surgeon to place the lead and stimulate the nerve with

a stimulation -device-during -or-after the-surgerywithout requiring the surgeon-to hold

the stimulation device in place. In an aspect, the stimulation may take place generally

after a procedure for a predetermined period (e.g., i minutes, where i is a number). In

at least one embodiment, the stimulation may take place for about an hour or less after

a procedure has been completed. Stimulation immediately after a procedure (e.g.,

nerve transfer or nerve release) may increase the speed, quality, or amount of nerve

regeneration. An aspect enables the onset of stimulation to begin in the operating

room, prior to procedure completion, and continuing into a post-operative setting, without disrupting stimulation. Reduction of the delay from the completion of surgical intervention to start of stimulation, may provide further clinical benefit.

[00371 In one example, electrical stimulation may be applied to determine a baseline

level of nerve excitability at the start of a surgery, i.e., a threshold test. During or near

completion of the surgery a second test of nerve excitability may be conducted. This

second test may be compared against the first. If the second test results in lower nerve

excitability, prolonged stimulation may be applied after the surgery to help with nerve

regeneration. This entire series of tests may be done with a single electrode and

stimulation device or may be accomplished with two or more electrodes or

stimulation devices. Further still, the initial threshold test may be done with a different

stimulation and the same lead or a different stimulation device and lead or with the

same stimulation device and the same lead. The application of the second test may

determine if the nerve regeneration stimulation is necessary or desirable for the

patient, i.e., to treat any potential nerve injury or trauma as suggested by the reduction

in nerve excitability between the first and second test. The threshold test may

comprise electrical stimulation to a nerve or nerves within a target tissue region to

determine or measure the excitability of the nerve or nerves. In such situations, it may

only be necessary to-test nerve- excitability to determine-if the nerve--regeneration

therapy is needed prior to applying such nerve regeneration therapy. Threshold testing

may be done at any time during the surgery, such as when a retractor is removed, a

limb of a patient has a force applied to it or the like.

10038] In another example, stimulation of a nerve may be applied during surgery prior

to treatment or repair of nerve damage, suspected nerve damage, a risk of future nerve

damage, or the like. A percutaneous lead may be placed at or near a nerve (e.g., within

a range of the signal) to allow a stimulation device to generate and apply a signal to the nerve tissue. The stimulation may take place for a predetermined period of time and may be conducted at any time during surgery. For example, stimulation may occur immediately at the start of surgery and may be conducted for an hour or less. It is noted that the stimulation may be apply at different strengths, frequencies, patterns, or the like. Stimulation at time of a surgical operation may increase the speed, quality, or amount of nerve regeneration or nerve function recovery. The percutaneous lead may be anchored, held, or otherwise left in place after stimulation, during, and/or after a surgical operation.

[0039] As described herein, the parameters of the stimulation signal of the prolonged

stimulation may be preprogrammed or may be set by a surgeon. In at least one

embodiment, the pulse width may be held constant (e.g., not adjusted) during the

stimulation. In an aspect the stimulation signal may be applied at generally between

-100Hz, 15-30Hz, or about 16Hz. The amplitude of the stimulation may be held

constant or be adjusted by the surgeon. In general the stimulation amplitude will

generally be between 0.1-20mA, typically between 1.0-2.0mA. Moreover, the

stimulation signal may be applied for a prolonged period (e.g., an hour). It is noted

that the prolonged stimulation signal may be applied in a single dose or multiple

doses, or for durations up to _or _more than.8_hours._For example,multiple doses-may -

be applied through the same percutaneous lead, which may be kept in place between

doses or may be removed between the doses. In such examples, one lead may be

utilized and a different stimulation device utilized depending upon the location of the

patient during stimulation, i.e., , surgical location or post-operative location. In the

alternative, one lead may be utilized and a single stimulation device utilized

regardless of the location of the patient during stimulation. In yet another alternative,

a different lead and different stimulation device may be utilized depending upon the location of the patient during stimulation. In such dosing examples, the electrical stimulation may be applied for a period of time, such as k minutes, where k is a number (e.g., 1, 2, 5, 10, 15, 60, etc.). In an example, the period may be between about 10 minutes and an hour or more,

[0040] For example, stimulation systems described herein may intraoperatively

deliver, for a period of time, an electrical stimulation to repaired peripheral nerves. An

attachment (e.g., a percutaneous electrode lead attachment such as those described in

U.S. Patent Application US2014/0073985A, which is incorporated by reference

herein) may be coupled with a stimulation device after a surgical procedure. It is

noted that the stimulation device may be a stimulation device that was used during the

procedure. For instance, a surgeon may utilize a handheld stimulation device to access

nerve function during a surgical operation. The surgeon may place one or more

implantable leads at a position where the lead may stimulate nerves that may have

damage, potential for damage, or may require recovery after completion of the

surgical operation. It is important to note that the present disclosure contemplates

providing the electrical stimulation to be preventative, i.e., to mitigate the impact of a

nerve injury, risk of nerve injury, or suspect nerve injury. The surgeon may, for

instance, _place the handheld stimulation device into a sterilized container and may

electrically attach the one or more implantable leads to the handheld stimulation

device via ports of the container. As such, the patient's nerve may be stimulated post

operatively via the same stimulation device utilized for the surgical operation. Once

post-operative stimulation is completed (e.g., after 1 hour of stimulation), the

stimulation device may be discarded or otherwise removed.

[00411 The stimulation device may be disposable or reusable. Described systems may

allow a stimulation electrode to be placed intraoperatively, in close proximity to the nerve to be stimulated; allowing the lead to pass out of the tissue and attach to the stimulation device.

[00421 The stimulation device may provide a prolonged stimulation after an incision

is closed. At a desired stopping time, the lead may be removed post operatively, and

the prolonged course of stimulation may be discontinued. In an aspect, this may

eliminate the need for extended operating time, and may free up a surgeon or staff

from holding the stimulator on the nerve for prolonged stimulation. The lead may also

be left in for a period of time, to enable repeated doses of stimulation across multiple

days or weeks without need for placement of another lead.

[0043] The surgeon may place the stimulation device in a container. The container

may comprise a bag, box, or other container. The container may seal the stimulation

device within the container to prevent or reduce the chance of contamination, provide

stability, or the like. In at least one embodiment, the container may comprise one or

more ports that may allow the stimulation device to be coupled with a wire or lead.

The retum current electrode may be attached to a side of the container that is in

contact with a patient, or may be an external electrode that connects to a second port

on the container. As described herein, the container may comprise a suitable material

such as-aplastic,.vinyl, metal,.ornother-material.

[0044] It is noted that the disclosed systems and methods are applicable for use in a

wide variety of medical procedures involving peripheral nerves. By way of non

limiting example, the various aspects of the invention have application in treatment of

nerve transection injuries, nerve crush injuries, suspected nerve injuries, risk of nerve

injuries or function reduction, or nerve transfer procedures, including, without

limitation nerve decompression procedures (such as carpal tunnel or cubital tunnel

syndrome), neurolysis, nerve transfer, nerve repair (such as direct repair, autograft, allograft, or conduit), and iatrogenic injury (thermal, stretch, compression, or transection).

[00451 In at least one embodiment, an electrical stimulation system may comprise a

stimulation device and an adaptor. The stimulation device may comprise housing,

control circuitry operatively generating a stimulation signal, wherein the control

circuitry is disposed within the housing, and an operative element coupled with the

housing and comprising at least one electrode. The adaptor may be selectively

attached to the operative element, and may comprise a percutaneous lead electrically

coupled to the stimulation device through the at least one electrode, the percutaneous

lead insertable into a patient during a subcutaneous surgery and after the subcutaneous

surgery and wherein the stimulation device is capable of applying electrical

stimulation during the subcutaneous surgery and after the subcutaneous surgery. The

percutaneous lead may comprise a twisted wire.

[0046] The control circuitry may apply the electrical stimulation after the

subcutaneous surgery for nerve regeneration therapy. Nerve regeneration therapy may

comprise stimulation to a nerve to alter recovery (e.g., improve, enhance, accelerate,

etc.) of the nerve so stimulated. In another aspect, the control circuitry may apply the

electrical stimulation-for a_ period between 10-minutes-and one hour.The electrical-

stimulation system may further comprise a container operatively receiving the

stimulation device, wherein the container comprises at least one connection port that

operatively and electrically couples the stimulation device to the percutaneous lead. In

at least one embodiment, the electrical stimulation system may further comprise a

splitter device, operatively coupled to the stimulation device, electrical stimulation

system, and at least one other lead, wherein the splitter device receives the stimulation

signal and generates generally uniform output signals to the lead and the at least one other lead. The splitter device may be disposed within the container. The container may comprise an attachment device that operatively attaches the container to an object. The container may additionally or alternatively comprise one or more fasteners to selectively secure the control circuitry within the container. It is noted that the at least one connection port may comprise a return port that operatively receives a return electrode of the stimulation device from within the container. The return port may operatively and electrically couple the return electrode to a return lead.

100471 In another aspect, embodiments include a method for stimulating tissue may

comprise In another aspect, embodiments include a method for stimulating tissue may

comprise performing a subcutaneous surgery with a stimulation device, placing a lead

within range of a target tissue region, wherein the lead is operatively attachable to the

stimulation device, and applying a stimulation signal to the target tissue region with

the lead and the stimulation device before or after the subcutaneous surgery. Placing

the lead may comprise placing the lead percutaneously. The stimulation device may

be a handheld stimulation device. The method may include placing the stimulation

device within a container after performing the subcutaneous surgery and for nerve

regeneration therapy. It is noted that the method may include attaching the lead to an

external end.of a -port of the-container and attaching-the stimulation device to--an

internal end of the port. According to at least one example, the stimulation device is

placed within the container while in an operating room. Moreover, stimulating the

target tissue region with the lead and the stimulation device may be done prior to

performing certain portions of the subcutaneous surgery or during the subcutaneous

surgery to determine a threshold for excitability of a nerve within the target tissue

region, for the purpose of determining if application of prolonged stimulation for

nerve regeneration therapy is appropriate. In an aspect, the determined threshold for excitability may be utilized to determine if application of stimulation for nerve regeneration therapy is appropriate.

[0048] A method for stimulating tissue may comprise placing a lead within range of a

target tissue region and applying a stimulation signal with a stimulation device; and

performing a subcutaneous surgery with the handheld stimulation device before or

after applying the stimulation signal. The method may further comprise storing the

stimulation device within a container prior to moving out of an operative setting in

order to maintain sterility after and stability while moving a patient to another

location. In at least some embodiments, the method may comprise stimulating the

target tissue after performance of the subcutaneous surgery.

10049] Turning now to Figs 1 and 2, there is a stimulation system 100 that may

comprise a stimulation device 102 configured for locating, monitoring, and

stimulating tissue and other structures throughout the body. The stimulation system

100 may be utilized for locating and identifying tissue and safeguarding against tissue

and/or bone injury during surgical procedures. In another aspect, the stimulation

device 102 may be utilized for percutaneously stimulating a nerve after a surgery for a

desired amount of time. In an aspect, the stimulation may be post-operative

stimulation after asurgical procedure - ......

[0050] The stimulation device 102 may include or be coupled with one or more

attachments or operative elements including, for example, a probe 110 (e.g., which

may be blunt, needle-like, etc.), a cutting device, a drilling or screwing device, a pilot

auger, and a fixation device. It is noted that attachments may be removable,

attachable, or permanently affixed to the stimulation device 102. It is noted that while

embodiments may describe use of a particular attachment (e.g., probe 110) for simplicity of explanation, the various embodiments may utilize other types of attachments.

[0051] In an exemplary embodiment, stimulation device 102 comprises control

circuitry 104, disposed in a housing 120, that may apply a stimulation signal to a

desired tissue region. The control circuitry 104 may be coupled to a power source,

such as a battery, power mains, or the like. The control circuitry 104 may generate the

stimulation signal with desired parameters, as described herein. In an aspect, a user

may adjust parameters and/or control the control circuitry 104 to generate the

stimulation signal via one or more user interfaces 108, which may comprise at least

one of a switch, button, slide, touch screen, or the like.

[00521 For instance, a user may grasp the stimulation device 102 via the housing 120.

The housing 120 may include gripping portion 122. The gripping portion 122 may

comprise indents, protrusions, elastomeric material, roughened material or other

features that may aid in the user grasping the stimulation device. The gripping portion

122 of the housing 120 may include an over molded portion that may comprise all or

part of the length of the housing 120. In an aspect, the over molded portion may

comprise a thermoplastic elastomer material. It is noted that gripping portion 122 may

be removable, attached to, or. integrally formed.with the housing 120.

[0053] In an example, a user may position the probe 110 so that an uninsulated or

stimulating portion or electrode 114 is at a desired location. The user may interact

with one or more of the user interfaces 108 to control delivery of stimulation signal,

generated by the control circuitry 104, to the desired tissue region. The gripping

portion 122 may aid in a user's efforts to hold the stimulation device 102. In an

aspect, the control circuitry 104 communicates the stimulation signal to the stimulation probe 110 via a lead 112 that may travel through an insulated portion"112 of the probe to the uninsulated portion 114.

[0054] It is noted that the probe 110 may comprise one or more flexible materials

(e.g., metal, plastic, etc.) so that a user may bend or otherwise manipulate the probe

110. In another aspect, the stimulation device 102 may comprise a nose cone 124 that

may be flexible or rigid. An operative element (e.g., probe 110) may extend from the

proximal end of the nose cone 124. The user may apply pressure to the nose cone 124

so that it moves or otherwise manipulates the probe 110. This may allow a surgeon or

other user to position the uninsulated portion 114 at a desired position of a targeted

tissue region. For example, the uninsulated portion 114 of the probe 110 is positioned

in electrical conductive contact with at least one of muscle, nerve, or other tissue.

[00551A flexible nose cone 124 may allow the surgeon to use either a finger or a

thumb positioned on the nose cone 124 to make fine adjustments to the position of

stim probe 110 at the targeted tissue region. The surgeon may grasp the housing 120

with the fingers and palm of the hand, and position the thumb on the nose cone 124,

and with pressure applied with the thumb, cause the probe 110 to move while

maintaining a steady position of the housing 120. This flexible nose cone 110 may

allowfor increased control-of the position of the probe 110 with the movement of-the

surgeon's thumb (or finger, depending on how the stimulating probe is held). In

another aspect the nose cone 124 may comprise gripping components, such as ribs,

indents, roughened surfaces, or the like.

[0056] It is noted that the nose cone 124 may comprise a single piece or it may

comprise one or more pieces attached together. For example, nose cone 124 may

comprise an inner portion that may include thermoplastic material having flexibility

(e.g., LUSTRAN.RTM. ABS 348, or similar material), and an outer portion that may comprise a softer over molded portion and may be made of a thermoplastic elastomer material having flexibility (e.g., VERSAFLEX.TM. OM 3060-1 from GLS Corp). It is noted, however, that nose cone 124 may be generally rigid in at least some embodiments.

[00571 While described as a "cone" nose cone 124 may comprise a generally tapered

shape. It is noted, however, that nose cone 124 may comprise other or different shapes

(e.g., rounded, squared, prism, conical, etc.). Moreover, in embodiments, stimulation

device 102 may not comprise a nose cone 124, such that probe 110 extends directly

from housing 120.

[0058] As described herein, a simulation signal may flow from the stimulation device

102 through the lead 112 to the probe 110, which may act as an electrode, The

stimulation system 100 may include one or more other electrodes, such as a return

electrode, as described herein. For instance, in monopolar operation, a return electrode

(or indifferent electrode) provides a return path for electrical signals passing through

the tissue, and retuming to the stimulation device 102. It is noted that stimulation

system 100 may operate in a monopolar, bipolar or other configurations, as described

here as well as elsewhere in this disclosure.

[0059] In- various_ -embodiments,- the- control circuitry- 104 may- generate the

stimulation signal to operatively generate a physical motor response of a tissue (e.g.,

muscle, innervated muscle, nerve, etc.). The physical motor response may indicate

whether the stimulation signal was delivered and/or whether a sufficient stimulation

signal was delivered. For example, the motor response may include a physical motor

response (e.g., twitching or contraction).

[0060] In another aspect, the stimulation device 102 may generate one or more visual

or audio signals (e.g., via a speaker (not shown)), which indicate to the surgeon the status or diagnostic information. For instance, stimulation device 102 may comprise an indicator light 126. The indicator light may comprise one or more light sources, such as a light emitting diode (LED). In an aspect, the indicator light 126 may comprise a translucent (e.g., semi-translucent, fully translucent, etc.) surface that operatively shines or disperses light from an internal light source (not shown). In an aspect, the light source may generate light in one or more colors (e.g., green, yellow, blue, red, etc.), patterns (e.g., blink rate, pattern of colors, etc.), or the like. According to embodiments, the status or diagnostic information may indicate whether the stimulation signal was delivered and/or whether a sufficient stimulation signal was delivered. For example, the status or diagnostic information may indicate that an electric signal was returned from tissue, which may indicate sufficient proximity, contact, or delivery of a stimulation signal via an operative element (e.g., probe 110).

In another aspect, the indicator light 126 may indicate that the stimulation device 102

is on/off, producing or not producing a stimulation signal, or the like.

10061] In an example, the indicator light 126 allows the surgeon to confirm delivery

of stimulus current to tissue. Through the use of different tones, colors, different flash

rates, etc., the indicator 126 allows the surgeon to confirm that the uninsulated tip 114

is in place, the-instrument is turned ON, and that stimulus current is flowing with -

sufficient delivery to tissue. Thus, the surgeon has a much greater confidence that the

desired stimulation amplitude is being delivered to the nerve, as in the case of a nerve

transfer of nerve graft, a muscle contraction will not be observed since the nerve is no

longer in continuity. These indicators can be checked periodically to ensure

stimulation is being delivered for the desired duration (e.g. between about 1 minutes

and one hour).

[0062] As another example, in use the indicator 126 may be configured to illuminate

continuously in one color when the stimulation device 102 is turned on but not in

contact with tissue. After contact with tissue is made, the indicator 126 may flash (i.e.,

blink) to indicate that stimulation is being delivered. If the stimulation has been

requested, i.e., the stimulation probe has been turned on, but there is no stimulation

being delivered because of a lack of continuity between the probe 110 and the return

electrode 130, or an inadequate connection of the probe 110 or the return electrode

130 to the patient tissue, the indicator 126 may illuminate in a different color, and

may illuminate continuously or may flash.

[0063] As described herein, the indicator 126 may comprise a ring that provides a

visual indication around at least a portion, and desirably all of the circumference of

the stimulation device 102 generally near the nose cone 124. A ring indicator may be

an element of the gripping portion 122, or it may be an element of the flexible nose

cone 124, or the ring indicator may be positioned between the gripping portion 122

and the nose cone 124. The ring may also include a reflective element to improve and

focus the illumination effect of the light emitting source, e.g., one or more LEDs. The

ring and the reflective element may be a single component, or more than one

component. Audio feedback also-makes possible the feature of-assisting- the surgeon

with monitoring nerve integrity during surgery.

[0064] While stimulation device 102 is described as generating an indication, it is

noted that various other components of the stimulation system 100 may generate all or

part of the indication. For instance, the stimulation device 102 (or a separate device)

may monitor delivery of the stimulation signal. The stimulation device 102 may

transmit status and diagnostic information (e.g. delivered current stimulation

duration, contraction presence, or the like) to a separate device (e.g., laptop, wearable electronic device, cellular phone, tablet, computer, speakers, light source, or the like).

In an aspect, the stimulation device 102 may include a communication component that

may be wired or wireless. For example, the stimulation device 102 may include a

wireless transmitter/receiver configured to communicate via one or more

communication protocols (e.g., Wi-Fi, BLUETOOTH, NFC, etc.).

[0065] In embodiments, stimulation device 120 may comprise a hand-held

stimulation device. Housing 120 may be generally tubular, hexagonal, or other

elongated shape. According to an aspect, the housing 120 may be ergonomic and

sterile for use in operative procedures. For instance, the stimulation device 120 may

be packaged in a sealed container that may allow a surgeon to open and use the

stimulation device 120 without the need for sterilization. It is noted, however, that

parts of the stimulation system 100 may be sterilized, such as probe 110. In another

aspect, the stimulation device 120 may comprise a single use instrument for use

during surgical procedures to identify nerves and muscles, muscle attachments,

contract muscles to assess the quality of surgical interventions or the need for surgical

interventions, evaluate the function of nerves already identified through visual means,

or provide prolonged stimulation of a nerve.

[0066] The stimulation device 120 may be sized small-enough to be-held and used by

one hand during surgical procedures, and may be ergonomically designed for use in

either the left or right hand. In an embodiment, the stimulation device 120 may have a

width of about 20 millimeters to about 30 millimeters, and desirably about 25

millimeters. The length of the stimulation device 120 (not including an operative

element) may be about 18 centimeters to about 22 centimeters, and desirably about 20

centimeters. An operative element (e.g., probe 110) may also include an angle or bend

116 to facilitate assess to deep as well as superficial structures without the need for a large incision. As illustrated, the bend 116 may be generally downward, relative the directions shown in Figs 1 and 2. In an aspect, this may allow a surgeon to maintain a line of sight with target tissue and/or the uninsulated portion 114.

[0067] In one or more embodiments, as described here as well as elsewhere in this

disclosure, an operative element may be mono-polar or bi-polar. For instance, probe

110 may be mono-polar. A return electrode 130 may be coupled to control circuit 104

via an insulated wire 132. The return electrode 130 may comprise any of a variety of

electrode types (e.g., paddle, needle, wire, or surface electrode). In another aspect, the

stimulation device 102 may be bipolar and may comprise a return electrode in the

probe 110 or other operative element.

[00681 User interfaces 108 may allow a user to turn ON/OFF the stimulation device

102 (or set to standby), and may allow a user to control the stimulation signal

amplitude selection within a predefined range (e.g., 0.1 0.5, 2.0, and/or 20 mA). In

configurations, user interface 108 may be a four or five position switch. It is noted

that the user interface 108 may allow for selection and change of frequencies within a

range. Before the first use of the stimulation device 102, the user interface 108 is in

the OFF position and keeps the stimulation probe off. After the user interface 108 has

been turned-ON_(eg., by moving the switch-155 to an amplitude-selection), the OFF

position now corresponds to a standby condition, where no stimulation would be

delivered. In one embodiment, once the stimulation device has been turned on, it

cannot be turned off, it can only be returned to the standby condition and will remain

operational for a predetermined time, e.g., at least about seven hours. This may allow

the stimulation device 102 to be only a single use device, so it cannot be turned OFF

and then used again at a later date It is noted, however, that some embodiments may

allow the user to turn off the stimulation device 102 after it has been turned on. In one example, the user interfaces 108 may allow for selection of "prolonged stimulation."

Once prolonged stimulation has been selected, the stimulation device 102 may disable

user control of certain stimulation parameters, may allow the stimulation device 102

to be turned off, or may turn off after a certain time in the prolonged stimulation mode

(e.g. 1 hour).

[0069] The user interfaces 108 may allow for adjustment of a stimulation signal pulse

width from a predefined range (e.g., about zero to about 200 microseconds). In one

embodiment, the user interfaces 108 may be a potentiometer to allow a slide control to

increase or decrease the stimulation signal pulse width within the predefined range.

The stimulation pulse may have a non-adjustable frequency in the range of about 10

Hz to about 30 Hz, and desirably about 16 Hz. In some embodiments, the stimulation

pulse may comprise an adjustable frequency.

100701 As a representative example, the stimulation pulse may have a biphasic

waveform with controlled current during the cathodic (leading) phase, and net DC

current less than 10 microamps, switch adjustable from about 0.1 milliamps to about

milliamps, and pulse durations adjustable from about zero microseconds up to

about I millisecond.

[0071JThe-operative element (e.g, probelt10)_exits.or attaches to the housing 120 at

the nose cone 124 to deliver stimulus current to the excitable tissue. The probe 110

comprises a length and a diameter of a conductive material, and is desirably fully

insulated with the exception of the uninsulated portion 114, e.g. about 1.0 millimeters

to about 10 millimeters, and desirably about 4 millimeters to about 6 millimeters,

which is non-insulated and serves as the stimulating to allow the surgeon to deliver

the stimulus

[0072] The size of the uninsulated portion 114, (the active electrode) of the probe 110

ensures a high current density that will stimulate nearby excitable tissue, The

insulation portion 112 may comprise a medical grade heat shrink.

[0073] The conductive material of the probe 110 comprises a diameter having a range

between about 0.5 millimeters to about 1.5 millimeters, and may be desirably about

1.0 millimeters. The length of the operative element 110 may be about 50 millimeters

to about 60 millimeters, although it is to be appreciated that the length may vary

depending on the particular application. As shown, the probe 110 may include one or

more bends to facilitate accurate placement of the uninsulated portion 114. In one

embodiment, the conductive material of probe 110 is made of a stainless steel, solid

wire, although other conductive materials may be used. Further, the probe 110 may

include an anchor 116. The anchor 116may be of any appropriate configuration. By

way of a non-limiting example, the anchor 116may comprise a bend in the probe 110

such that upon insertion of the probe 110 into tissue of a patient, or more specifically,

the anchor 116being inserted into tissue of the patient, the anchor 116prevents an

undesired withdrawal of the anchor 116and/or probe 110.

[0074] As previously described, in monopolar operation, a return electrode 131 (or

indifferent electrode), for example, provides an-electrical path from the body-to the

stimulation device 102. The return electrode 130 may be placed on the surface of

intact skin (e.g., surface electrodes as used for electrocardiogic orelectromyographic

monitoring during surgical procedures) or it might be needle-like and be placed in the

surgical field or penetrate through intact skin or an incision.

[00751 The configuration of the stimulating medical devices that form a part of the

system can vary in form and function. Various representative embodiments of

illustrative medical devices will be described.

[00761 Referring now to Figs 3-4A, there are percutaneous electrodes 300 and 400 in

accordance with various disclosed aspects. Percutaneous electrodes 300 and 400 may

generally include an insulated body 302/402, an anchor 304/404, and one or more

uninsulated portions 306/406. It is noted that percutaneous electrode 300 may

comprise similar aspects as percutaneous electrode 400, unless context suggest

otherwise or specific reference is made to a difference between the two. As such,

while examples may refer to one of the percutaneous electrodes 300 and 400 for

simplicity of explanation, the other may be utilized. Moreover, various other

percutaneous electrodes may be utilized by embodiments disclosed herein.

[0077] In an example, percutaneous electrode 300 may be placed at or near a target

tissue region and may be coupled with a percutaneous lead or wire, as described

herein. It is noted that percutaneous electrode 300 may be positioned while an incision

is open and may be left in place while the incision is closed. In at least one other

embodiment, percutaneous electrode 300 may be positioned when an incision is

closed or by deploying the percutaneous electrode 300.

[0078] In embodiments, percutaneous electrode 300 may comprise strands of stainless

steel wire insulated with a biocompatible polymer. Each wire strand may have a

diameter of approximately_34.mand the-insulated multi-strand lead wire may have a

diameter of approximately 250 pm. It should be understood, however, that these

dimensions are merely exemplary and the present teachings are not limited to such.

Any appropriate sized, shaped and configured electrode and percutaneous lead may be

used. The insulated wire may be formed into a spiral or helix as has been found to

accommodate high dynamic stress upon muscle flexion and extension, while

simultaneously retaining low susceptibility to fatigue. The outer diameter of the

percutaneous electrode 300 may be approximately 580 m and it may be encased or filled with silicone or the like. In at least some embodiments, percutaneous electrode

300 may be made out of a different material (e.g., another metal, conducting

polymer), may be insulated with another material, or may not be insulated, Further,

the lead may be cylindrical or paddle-like.

10079] Unlike surface electrodes that are applied to the surface of the patient's skin

using an adhesive, percutaneous electrode 300 may be surgically implanted or

otherwise inserted into select tissue. The terminal end or anchor 304 may comprise

one or more tines 308 (e.g., tines 408 of percutaneous electrode 400). The anchor 304

may be insulated or uninsulated. In at least some embodiments, the anchor 304 may

be inserted directly into tissue and may deliver stimulation signals to the tissue. In

another aspect, the anchor 304 may generally hold the percutaneous electrode 300 in

place. For instance, the one or more tines 308 may comprise a bend, curve, barb, etc.,

that prevents the percutaneous electrode 300 from substantially moving or

unintentionally coming loose. As shown in Figs 3 and 4, disclosed embodiments may

include different types of anchors 304/404. For instance, an anchor may include j

tines, where j is a number. In an exemplary embodiment, a patch assembly may be

utilized in conjunction with the percutaneous electrode 300. The patch assembly may

comprise. several layers, -including an adhesive layer---an- electrode layer, a

reinforcement layer and a cover layer. In one embodiment, the patch assembly may

include a power source for the stimulation device. Further, the patch assembly may

act as a surface electrode. In one embodiment, the patch assembly may include

engagement member or members that electrically couple the stimulation device to the

percutaneous electrode 300 to provide stimulation for nerve regeneration. The

engagement member may comprise a snap, a magnetic male and female member

capable of operable engagement, a bayonet engagement device, or any know engagement mechanisms capable of electrically coupling the stimulation device with the percutaneous electrode 300. The present disclosure contemplates any such configuration of the patch assembly.

[0080] In another aspect, an anchor may include threaded members (e.g., screws) or

the like. Further still, the percutaneous electrode 300 may not include any tines or

anchors. In these embodiments, the percutaneous electrode 300 may be placed near or

around, i.e., generally circumscribing all of or a portion of the applicable nerve.

Further, the percutaneous electrode 300 may be placed over, i.e., on top of or at the

bottom of, the applicable nerve, or near, i.e., in an operative distance from the

applicable nerve in any manner. The present teachings are not limited to a specific

configuration. Embodiments may include a nerve cuff, a coiled lead, a straight lead,

lead with a hook, lead with a tine or tines, or the like.

[0081] According to embodiments, percutaneous electrode 300 may comprise flexible

materials that allow some or all of the percutaneous electrode 300 to bend or deform.

In an example, the insulated portion 302 may be a lead that is generally flexible to

allow removal, positioning, or other manipulation of the percutaneous electrode 300.

[0082] In embodiments, sections of the uninsulated portion 306 may be separated by

insulated portions 310(e.g.,. insulation. portions Al0 _in FIG. 4A). It is noted that

different sections of the uninsulated portions 306 may be electrically isolated from

each other to allow for bipolar stimulation. In another aspect, the insulated portions

310 may allow for increased strength, positioning, or the like of the percutaneous

electrode 300. The uninsulated portion 306 may operatively deliver a stimulation

current. It is noted that the uninsulated portion 306 may be disposed anywhere along

the percutaneous electrode 300. For instance, the uninsulated portion 306 may be

disposed at one or more tines 308, at anchor 304, or the like.

[0083] FIG. 4B illustrates another percutaneous electrode 450 comprising an

insulated body 452 and an anchor 454. The anchor 454 may comprise a twisted or

braided wire. The anchor 454 may be electrically conducting and not insulated such

that it may apply a stimulation signal to tissue. In an aspect, the anchor 454 may

comprise a helical portion 458. In another aspect, body 452 may include twisted,

braided or helical portion 460. The helical portion 458 and helical portion 460 may

anchor the percutaneous electrode 450 in places. In an aspect, the percutaneous

electrode 450 may allow for extended use or implantation. For example, tissue may

heal around the helical portion 458 or helical portion 460. The shape of these portions

allows tissue to grasp and grow in between turns or bends of the helical portion 458

and helical portion 460. The tissue growth will anchor the percutaneous electrode 450

and may prevent or reduce chances of developing infections as the tissue heals around

the percutaneous electrode 450. This may allow the electrode 450 to remain in place

for an extended period of time or for a short period of time. Further, the helical

portion 460 may comprise a fine-coiled wire with a insulative material surrounding

such.

100841Turning now to Figs 5-7, with reference to Figs 1-4, there are adaptor 500

(which includes percutaneous electrode-400 (and may also include electrode-300-and

450) and a lead wire 502), adaptor 600 (which may be coupled to a stimulation device

and/or percutaneous electrode), and stimulation system 700 (which may include

stimulation device 102). It is noted that liked named components of the various

embodiments may comprise similar aspects, unless context suggests otherwise or a

particular distinction is made.

[OOSSI In an embodiment, adaptor 500 may primarily include percutaneous electrode

400, wire 502 and connector 512. Wire 502 may connect terminal end 412 of the percutaneous electrode 400 with connector 512. In an aspect, wire 502 may comprise an insulated wire that is removably or irremovably attached to the percutaneous electrode 400 and/or connector 512. As described herein, the adaptor 500 may be configured to allow a stimulation probe 110 to deliver a stimulation signal below the skin of a subject patient.

[0086] In an aspect, connector 512 may include an opening 514 that may receive an

operative element. As shown in FIG. 7 the opening 514 may receive the probe 1.1.0 of

a stimulation device 102. The opening 514 may be tapered to maintain the probe 110

in a. friction fitwithin theconnector 512. The connector may further include other

retaining features. such as a fastener (e.g., screw, clasp, threaded portions, VELCRO,

magnet, etc.) to retain the connection between the connector 512 and the probe 110. It

is noted that connector 512 may comprise an electrical connection disposed within the

connector 512 that may operatively couple an uninsulated or stimulating portion of

the probe 110 with the wire 502

[0087] Wire 502 may extend from the connector 512. Wire 502 may be an electrical

conductor in electrical connection with probe 110 when probe 110 is operatively

inserted into the connector 512. It is noted that the wire 502 may beany appropriate

length, such as 24 inches ora length between12.inches and48inches.-The Iead wire

may further be any appropriate gauge, such as 24 AWG wire.

[0088] Percutaneous electrode 400 may be coupled to the wire 502 at a terminal end

412. According to an embodiment, the wire 502 may be removably or irremovably

coupled to the terminal end. It is noted that the wire 502 may be coupled directly to

the terminal end 412 and/or may be coupled indirectly to the terminal end 412, such

as through one or more other connectors (not shown). Moreover, wire 502 may be

coupled to other portions of the percutaneous electrode 400. In an aspect, the connection between the wire 502 and the percutaneous electrode 400 may be insulated or uninsulated.

[00891 As shown in FIG. 6, adaptor 600 may comprise a wire 602 and one or more

connectors 612/622, Each connector 612/622 may comprise an opening 614/624. In

an aspect, openings 614/624 may comprise similar or different dimensions. For

instance, openings 614/624 may be operatively sized and shaped to receive an

operative element and/or a percutaneous electrode (e.g., percutaneous electrode

300/400). In at least one embodiment opening 614 is operatively sized to receive an

operative element, and opening 624 is operatively sized to receive a percutaneous

electrode. In another aspect, connectors 612/622 may comprise elastomeric materials

that may stretch, compress, or otherwise fit different sized components. Moreover,

while embodiments disclose connectors 612/622 as female connectors, it'is noted that

one or more of connectors 612/622 may be a male connector. In another aspect, wire

602 (or 502) may comprise one or more branches or pathways such that connector

614, for example, may be electrically coupled with one or more other connectors

through wire 602.

[0090] Turning to FIG. 7, and as described herein, system 700 may comprise

stimulation-device 102 that may-be coupled with an adaptor 500 (or-other-described

adaptors). In an aspect, a surgeon may utilize stimulation device 102 during a

procedure (e.g., location of a nerve, nerve assessment, etc.) When the procedure is

complete, the surgeon may place a percutaneous electrode in a desired location. The

surgeon may couple the electrode to the stimulation device 102 via connector 500.

[0091] As illustrated, connector 512 may be attached to the probe 110. The surgeon

may utilize user interfaces 108 to select a stimulation process, For instance, the

surgeon may operatively set the stimulation device 102 to deliver a prolonged stimulation to target tissue. In an aspect, prolonged stimulation may follow completion of a surgical intervention (e.g. nerve repair, nerve release, or nerve transfer). In an aspect, prolonged stimulation may be delivered to a nerve or muscle, distal to site of surgical intervention, to increase muscle viability while the nerve re grows.

[0092] It is noted that the stimulation device 102 may comprise a preprogrammed

stimulation process that may operatively generate stimulation signals for prolonged

stimulation. In another aspect, user interfaces 108 may allow a user to manually

program or adjust stimulation parameters, such as intensity, pattern, time, or the like.

[0093] Figs 8-10 illustrate a container 800 that may operatively receive a stimulation

device (e.g., stimulation device 102). FIG. 11 illustrates the stimulation device 102

disposed within the container 800 and coupled with adaptor 500, The container 800

may operatively hold the stimulation device for transitioning a patient to post-op or

during post-op. This container may be used to hold a stimulation device that was

previously used during the procedure, isolating the device with potential biological

contamination (e.g. blood) from the rest of the environment. It is noted that container

800 may comprise various materials, such as one or more of plastic, metal, or the like.

In at least oneembodiment,.container 800 may comprise a sterilized material.

10094] A body 802 of the container 800 may comprise a terminal end 804 and a

proximal end 806. The terminal end 804 may comprise an opening 808 that may allow

a surgeon to insert the stimulation device 102 in the container 800, and seal the

container. It is noted that various other sides or portion of the body 802 may comprise

an opening to allow the surgeon to place the stimulation device 102 in the container

800.

3t

[0095] According to an embodiment, container 800 may comprise one or more

fasteners 810 that may fasten or hold the stimulation device 110 when inserted into

the container 800. The fastener 810 may include a hook, clasp, screw, adhesive, or

other fastener. For example, fastener 810 may comprise a clasp that may be sized and

shaped to allow body 120 of stimulation device 102 to snap into the clasp. In an

aspect, the clasp may friction fit with the body 120 to maintain the stimulation device

102 in a general position relative the container 800.

[0096] Body 802 may comprise one or more ports, such as port 812 and port 814. Port

812 and port 814 may be disposed and various locations, in an example, port 812 is

disposed at a location to allow an operative element of stimulation device 102 to be

inserted or otherwise coupled to port 812 when the stimulation device 102 is attached

to the fastener 810. Port 814 may operatively receive return electrode 130. It is noted

that port 812 and port814 may be positioned generally proximal each other or may be

positioned at other locations.

[0097] It is noted that ports 812 and 814 may allow components disposed within the

container to be electrically coupled to components disposed outside of the container.

In an example, the port 812 may receive a connector (e.g., connector 512 as shown in

expanded view 1100).F or instance, port 812 may receive a portion of connector 512

and may operatively hold the connector 512 in place (e.g., via a friction fit, fastener,

or the like).

[0098] In at least one embodiment, the port 812 (and/or 814) may comprise a

connector 512 that is built into the container 800. For instance, a user may place the

stimulation device 110 in the container 800and may insert the port 812 into the

connector 512 and the retum electrode in another connector of port 814. The user may

seal the container 800. The user may connect the adaptor 500 to the port 812 from outside of the container 800. In another aspect, the user may connect a return electrode 1102 to the port 814 via a wire 1104 and/or another connector. According to an aspect, this may reduce or prevent the spread of material (e.g., bodily fluids, etc.) on the stimulation device 110 from exiting the container 800 during post-op procedures.

[0099] In at least one aspect, body 802 may contain an electrode 816 attached to the

outer surface of the container. This electrode 816 may be electrically connected to the

return electrode of the stimulation device through port 814. In this embodiment the

integrated system would reduce the need for connection of an additional return current

electrode such as 1102.

1001001 In another aspect shown in FIG. 11, body 802 may include an

attachment device, such as a strap 124 that may facilitate attaching the container 800

to an object, such as a patient's limb, a belt, hospital equipment or the like, Various

other attachment devices may be utilized, such as hook and loop materials, magnets,

elastic, or the like.

[001011 Figs 12-14 illustrate a splitter device 1200 that may operatively split a

stimulation signal and/or return signal. According to embodiments, the stimulation

device 1200-generally include a housing 1202 that houses circuitry -1220.The-hosing

may include an input port 1206 and one or more output ports 1212, 1214,1216, and

1218. It is noted that splitter device 1200 may include any number of input or output

ports. Intemal circuity therein may be utilized to deliver one input signal to multiple

output channels, maintain current level at set output, such as for example at 1.0 or 2.0

mA.

[00102] Splitter device 1200 may receive a first wire 1230 via input port 1206.

In an aspect, the first wire 1230 may be coupled to a stimulation device (not shown) that may operatively apply a stimulation signal to the input port 1206. The circuitry

1220 may split the stimulation signal to one or more of the output port(s) 1212, 1214,

1216, 1218, which may be coupled to one or more operative elements, percutaneous

leads (e.g., percutaneous leads 300, 400, etc), non-percutaneous leads, or connectors

as described herein. In an example, a surgeon may place percutaneous leads 400 in

different target tissue in one or more patients. The surgeon may attach the

percutaneous leads 400 to the splitter device 1200 and may attach a stimulation device

to the splitter device. The stimulation device may apply a prolonged stimulation signal

to multiple tissue regions based via the splitter device 1200 and/or percutaneous leads

400.

[001031 As described herein, the circuitry 1220 may be an interface between a

stimulation signal (received at input port 1206) and divides the input signal to one or

more output signals with attached electrodes, selectively output at one or more of

output port(s) 1212, 1214, 1216, and 1218. This may allow the stimulation device to

utilize additional channels or contacts than otherwiseavailable.

[00104] It is noted that the circuitry 1220 may include a power source (e.g.,

battery) or may receive power from the stimulation device or other external source. In

S .an example, the_ circuitry may -comprise--an inductive circuit that operatively stores

power in one or more capacitors. According to another embodiment, the input signal

received at input port 1206 may supply the power. The circuitry may include the

components to ensure output remains within a specified range (e.g. 2.OmA) whenever

a stimulation pulse is delivered to the input port. Moreover, the circuitry 1220 may

include a demodulator (e.g. to receive and decode information) and one or more

switches or registers that control output to percutaneous leads 400 or other electrical

contacts, or the like, In an aspect, the switches may be utilized to detect whether an electrical contact is connected to output port(s) 1212, 1214, 1216, and 1218 such that power may be selectively applied to the ports.

[001051 In embodiments the splitter device 1200, or aspects thereof, may be

disposed on or within a container (e.g., container 800), or placed on the body outside

the container. For instance, the housing 1202 may be disposed within layers of

material in the container 800. In another aspect, the circuitry 1220 may be disposed

within the material of the container 800 (e.g., the housing may comprise the material

of the container). The splitter device 1200 may be sterilized.

[00106] According to various embodiments, splitter device 1200 may comprise

a clip, fastener, magnet, etc., that operatively attach the splitter device to a patient,

clothing, hospital equipment, or the like.

100107] Figs 15-17 illustrate a stimulation system 1500 primarily comprising a

simulation device 1501. The stimulation device 1501 may operatively control

stimulation of tissue via one or more stimulating medical devices including, for

example, simulation device 1501, probe 1510, percutaneous electrodes 300/400,

cutting devices, drilling devices, augers, fixation devices or the like. The stimulation

system 1500 may comprise an external stimulator that is selectively attachable ex

vivo a patient.-The stimulation-system 1500 may comprise a box-that may be attached

to a patient, such as by adhering to a patch assembly or other adhesive deice attached

to a patient, selectively attaching the box to clothing of a patient, including a strap or

necklace that a patient can wear to hold the box, using Velcro to attach the box to the

patient or patient's clothes, and the like.

[00108] In an aspect, the stimulation device 1501 may comprise circuitry that

operatively generates an electrical stimulation signal to be applied to a tissue. In an

aspect, the stimulation device 1501 may comprise similar functionality as described with reference to other stimulation devices (e.g., stimulation device 102). Moreover, stimulation device 1501 may comprise a user interface 1508, including a display

1502. As described herein, the user interface 1508 may comprise input/output devices

that operatively receive user input. A user may interact with the user interface 1508 to

adjust parameters of the stimulation signal and/or receive information from the

display 1502. For example, the display 1502 may indicate to a user the length of time

of the current therapy has left, the time the therapy has been applied, the number of

doses of therapy applied and/or number of therapies yet to be applied. By way of a

non.limiting example, if the therapy has an intended duration of an hour and twenty

minutes of therapy has been applied, the display 1502 may show that there are forty

minutes left on the therapy. The display 1502 may comprise an LED screen that can

provide any of the information indicated in the present disclosure to the user, patient

and/or clinician. Moreover, stimulation device 1501 may comprise a user interface

1508, including a display 1502 and audio feedback. In at least some embodiments, the

user interface 1508 may generate an alert that is audible, visual, tactile (e.g.,

vibration), or combination of the above. For instance, the user interface 1508 may

generate alerts to indicate that therapy is complete, a lead has moved, a lead has

become disengage,stimulation-has been disruptedan-error has occurred, a warning

(e.g., power supply is low), or the like. As described herein, the user interface 1508

may comprise input/output devices that operatively receive user input. The display

1502 with or without additional audio tones may display to the user signals recorded

on the one or more input ports 1506, which may be connected to other sensors

or systems to record physiologic signals such as pressure, electromyograms, stretch,

force, or the like. In an aspect, the stimulation device 1501 may include a

communication component that may be wired or wireless. For example, the stimulation device 1501 may include a wireless transmitter/receiver configured to communicate via one or more communication protocols (e.g., Wi-Fi, BLUETOOTH,

NFC, etc.).

[00109] Stimulation device 1501 may include one or more output ports 1512

that may be operatively coupled with an operative element (e.g., a probe 100), one or

more percutaneous leads 400 and/or connectors 500 (e.g., as shown in FIG. 18), or

other components. According to one or more embodiments, the stimulation device

1501 may include one or more output ports 1506 that may be coupled to a return

electrode 1802 via a wire 1804. It is noted that the return electrode 1802 may

comprise a pad-type, needle, or other style electrode as described herein. In an

embodiment 1700, the return electrode 1516 may be affixed to the back of the

stimulation device 1512.

1001101 In embodiments, a first side 1510 of the stimulation device 1501 may

comprise user interfaces 1508 as described herein. A second side 1512, which may be

generally opposed to the first side 1510, may include return current electrode 1516.

The second side 1512 or sides of the device may operatively receive belt 1530. Belt

1530 may be coupled to an object, such as a patient, hospital equipment, or the like. It

is noted_ that stimulation device 1501 may be attachable to objects via--other-

components such as clips, magnets, VELCRO, adhesives, or the like. It is further

noted that stimulation device 1501 may be disposed within a container (e.g., container

800), as described with reference to Figs 8-11,

100111] As described herein, stimulation devices (e.g., stimulation device 102,

1501, etc.) may operatively apply prolonged stimulation to target tissue. In examples,

the prolonged stimulation may be applied post-op (e.g., after completion of. a

procedure). For instance, a surgeon may create an incision in a patient. The surgeon may utilize a stimulation device to apply a stimulation signal within the incision.

Although in some embodiments, no stimulation signal may be utilized during the

surgery. Instead, the stimulation may be applied only after the surgery, such as by way

of a non-limiting example, during sensory nerve repair, motor or mixed nerve where

clinician does not need to or otherwise utilize a stimulator for nerve identification. It

is noted that stimulation may be applied to motor or mixed nerves wherein the surgery

does not utilize stimulation during the surgery. Regardless of whether stimulation was

applied during surgery or after closing of the incision, the surgeon may place a

percutaneous lead in or proximal target tissue. The percutaneous lead may be attached

to a stimulation device. The stimulation device may apply a prolonged stimulation. In

examples, the stimulation device may be the same stimulation device utilized during a

procedure or may be a different stimulation device. In another aspect, the stimulation

device may be disposed in a container that generally prevents contamination by or

movement of the stimulation device.

100112] As described herein, after completion of the stimulation, a surgeon

may remove the percutaneous lead. In an aspect, the percutaneous lead may be pulled

out of target tissue.

[00113] The foregoing is-considered as illustrative only--of the principles of the

invention. Furthermore, since numerous modifications and changes will readily occur

to those skilled in the art, it is not desired to limit the invention to the exact

construction and operation shown and described. While the preferred embodiment has

been described, the details may be changed without departing from the invention,

which is defined by the claims.

Claims (19)

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

1. An electrical stimulation system, comprising:

a stimulation device comprising:

a housing; control circuitry operatively generating a stimulation signal,

wherein the control circuitry is disposed within the housing;

an operative element coupled with the housing and comprising

at least one electrode;

an adaptor selectively attached to the operative element, the adaptor

comprising:

a percutaneous lead electrically coupled to the stimulation

device through the at least one electrode, the percutaneous lead insertable into

a patient during a subcutaneous surgery and after the subcutaneous surgery

and wherein the stimulation device is capable of applying electrical stimulation

during the subcutaneous surgery and after the subcutaneous surgery; and

a splitter device provided between the stimulation device and

the percutaneous lead, and including an input port and one or more output

ports, the stimulation signal is input via the input port and output via the one or

more output ports, applying a prolonged stimulation signal to multiple tissue

regions.

2. The electrical stimulation system of claim 1, wherein the control

circuitry applies the electrical stimulation after the subcutaneous surgery to

accelerate or improve nerve recovery.

3. The electrical stimulation system of claim 1, wherein the control

circuitry applies the electrical stimulation for a period between 10 minutes and

one hour.

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4. The electrical stimulation system of claim 1 further comprising a container operatively receiving the stimulation device, wherein the container

comprises at least one connection port that operatively and electrically couples

the stimulation device to the percutaneous lead.

5. The electrical stimulation system of claim 4, wherein the splitter device, operatively coupled to the stimulation device, the percutaneous lead, and at

least one other lead, wherein the splitter device receives the stimulation signal

and generates generally uniform output signals to the lead and the at least one

other lead.

6. The electrical stimulation system of claim 5, wherein the splitter device

is disposed within the container.

7. The electrical stimulation system of claim 4, wherein the container

comprises an attachment device that operatively attaches the container to an

object.

8. The electrical stimulation system of claim 4, wherein the container

comprises one or more fasteners to selectively secure the control circuitry

within the container.

9. The electrical stimulation system of claim 4, wherein the at least one connection port comprises a return port that operatively receives a return

electrode of the stimulation device from within the container.

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10. The electrical stimulation system of claim 9, wherein the return port operatively and electrically couples the return electrode to a return lead.

11. The electrical stimulation system of claim 1, wherein the percutaneous

lead comprises a twisted wire.

12. A method for stimulating tissue, comprising:

providing a stimulation device;

placing a lead percutaneously within range of a target tissue region,

wherein the lead is operatively attachable to the stimulation device and

comprises a stimulation electrode;

stimulating the target tissue region with the lead and the stimulation

device during a subcutaneous surgery at a set of verification stimulation

parameters to determine a threshold for excitability of an injured nerve within

the target tissue region, and

determining whether application of stimulation for nerve regeneration

therapy is appropriate based on the threshold for excitability of the injured

nerve and if determined to be appropriate applying a stimulation signal to the

target tissue region with the lead and the stimulation device before or after a

subcutaneous surgery to alter recovery of the injured nerve.

13. The method of stimulating the tissue of claim 12, wherein the stimulation device is a handheld stimulation device.

14. The method of stimulating the tissue of claim 13 further comprising

placing the stimulation device within a container after performing the

subcutaneous surgery

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15. The method for stimulating tissue of claim 14, further comprising attaching the lead to an external end of a port of the container and attaching

the stimulation device to an internal end of the port.

16. The method for stimulating tissue of claim 14, wherein the stimulation

device is placed within the container while in an operating room.

17. A method for stimulating tissue, comprising:

placing a lead within range of a target tissue region and performing a

threshold confirmation electrical stimulation to determine or measure an

excitability of a nerve;

performing a subcutaneous surgery with the handheld stimulation

device before or after applying the threshold confirmation electrical stimulation;

and

applying a therapeutic stimulation signal with a stimulation device for

nerve regeneration therapy wherein the threshold confirmation electrical

stimulation is separate from the therapeutic stimulation signal and wherein the

threshold confirmation electrical stimulation is used to determine whether

application of the therapeutic stimulation signal is appropriate.

18. The method of claim 17, further comprising storing the stimulation

device within a container prior to moving out of an operative setting in order to

maintain sterility after and stability while moving a patient to another location.

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19. The method of claim 17, further comprising stimulating the target tissue

after performance of the subcutaneous surgery.

Dated this 2 8 th Day of March 2024

Checkpoint Surgical, Inc. Patent Attorneys for the Applicant MAXWELLS PATENT & TRADE MARK ATTORNEYS PTY LTD

28/03/24